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Cue Health Evaluating Warning Letter Received from Food and Drug Administration (FDA)

SAN DIEGO, May 14, 2024--(BUSINESS WIRE)--Cue Health Inc. (Nasdaq: HLTH), a healthcare technology company (the "Company"), has received a warning letter from the FDA about its Emergency Use Authorized (EUA) COVID-19 test. The Company is currently evaluating the letter and determining its response, with more information to follow in the next few days.

About Cue

Cue Health Inc. (Nasdaq: HLTH) is a healthcare technology company that empowers healthcare providers to streamline their ability to deliver value-based care with fast, highly accurate test results on demand. Cue received De Novo authorization from the U.S. Food and Drug Administration (FDA) for its COVID-19 test, which became the first home use respiratory test to receive this FDA approval. Cue also received Emergency Use Authorization from the FDA for its molecular Mpox test at the point-of-care. Cue, founded in 2010, holds over 100 patents and is headquartered in San Diego. For more information, please visit www.cuehealth.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240513451572/en/

Contacts

Investor Relations
ir@cuehealth.com

Press
Cue Health
press@cuehealth.com